NCT04940910Unknown不适用
A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Black Rice Bran Extract on Immune Enhancement
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes of Natural Killer cell activity
研究概览
简要总结
This study was conducted to investigate the efficacy and safety of Black rice bran extract on immune enhancement.
详细描述
This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Black rice bran extract on immune enhancement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men and women over 19 and under 75 years
- •After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
排除标准
- •If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
- •Those who received influenza vaccination within 3 months before first intake of intervention
- •Those who have a body mass index(BMI) of less than 18.5 kg / m^2 or greater than 35 kg / m^2 at the screening
- •Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic and gastrointestinal disorders
- •Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
- •Those who have received antipsychotic medication within 3 months before screening
- •Those who alcoholic or drug abuse suspected
- •Those who participated in other clinical trials within 3 months before screening
- •Laboratory test by show the following results
- •Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- •Serum Creatinine > 2.0 mg/dL
- •Pregnancy or breast feeding
- •Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
- •Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
结局指标
主要结局
Changes of Natural Killer cell activity
时间窗: baseline and 8 weeks
Natural Killer cell activity was measured in study baseline and 8 week. A ratio of effector cell and target cell was 2.5:1, 5:1, 10:1. (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100
次要结局
- Changes of Interleukin-2, Interleukin-12, Interferon-Gamma and Tumor necrosis factor-alpha(baseline and 8 weeks)
- Changes of Wisconsin Upper Respiratory Symptom Survey-21(WURSS-21)(baseline, 4 weeks and 8 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
研究点 (2)
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